NEUPOGEN 300 ug/mL
Filgrastim · INJECTION, SOLUTION · Amgen, Inc
NEUPOGEN is a injection, solution containing filgrastim at 300 ug/mL, taken intravenous. Manufactured by Amgen, Inc.
Key Facts
- Brand Name
- NEUPOGEN
- Generic Name
- Filgrastim
- NDC Code (Product)
55513-530- Manufacturer
- Amgen, Inc
- Strength
- 300 ug/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS, SUBCUTANEOUS
- Marketing Status
- Application #
- BLA103353
- Drug Class
- Leukocyte Growth Factor [EPC]
- Marketing Start
- 05/19/1997
Recall History
Amgen, Inc.
Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
Amgen, Inc.
Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE NEUPOGEN is a leukocyte growth factor indicated to Decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever ( 1.1 ) Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML) ( 1.2 ) Reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ e.g.‚ febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT) ( 1.3 ) Mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis ( 1.4 ) Reduce the incidence and duration of sequelae of severe neutropenia (e.g.‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia ( 1.5 ) Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiati…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Patients with cancer receiving myelosuppressive chemotherapy or induction and/or consolidation chemotherapy for AML Recommended starting dose is 5 mcg/kg/day subcutaneous injection, short intravenous infusion (15 to 30 minutes), or continuous intravenous infusion. See Full Prescribing Information for recommended dosage adjustments and timing of administration ( 2.1 ) Patients with cancer undergoing bone marrow transplantation 10 mcg/kg/day given as an intravenous infusion no longer than 24 hours. See Full Prescribing Information for recommended dosage adjustments and timing of administration ( 2.2 ) Patients undergoing autologous peripheral blood progenitor cell collection and therapy 10 mcg/kg/day subcutaneous injection ( 2.3 ) Administer for at least 4 days before first leukapheresis procedure and continue until last leukapheresis ( 2.3 ) Patients with congenital neutropenia Recommended starting dose is 6 mcg/kg subcutaneous injection twice daily ( 2.4 ) Patients with cyclic or idiopathic neutropenia Recommended starting dose is 5 mcg/kg subcutaneous injection daily ( 2.4 ) Patients acutely exposed to myelosuppressive doses of radiation 10 mcg/kg/day s…
Contraindications
4 CONTRAINDICATIONS NEUPOGEN is contraindicated in patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors such as filgrastim or pegfilgrastim [see Warnings and Precautions (5.3) ] . Patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors such as filgrastim or pegfilgrastim. ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Splenic Rupture [see Warnings and Precautions (5.1) ] Acute Respiratory Distress Syndrome [see Warnings and Precautions (5.2) ] Serious Allergic Reactions [see Warnings and Precautions (5.3) ] Sickle Cell Disorders [see Warnings and Precautions (5.4) ] Glomerulonephritis [see Warnings and Precautions (5.5) ] Alveolar Hemorrhage and Hemoptysis [see Warnings and Precautions (5.6) ] Capillary Leak Syndrome [see Warnings and Precautions (5.7) ] Myelodysplastic Syndrome [see Warnings and Precautions (5.8) ] Acute Myeloid Leukemia [see Warnings and Precautions (5.8) ] Thrombocytopenia [see Warnings and Precautions (5.9) ] Leukocytosis [see Warnings and Precautions (5.10) ] Cutaneous Vasculitis [see Warnings and Precautions (5.11) ] Aortitis [see Warnings and Precautions (5.15) ] Most common adverse reactions in patients: With nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs (≥ 5% difference in incidence compared to placebo) are pyrexia, pain, rash, cough, and dyspnea. ( 6.1 ) With AML (≥ 2% difference in incidence) are pain, epistaxis and rash…
Frequently Asked Questions
What is NEUPOGEN used for?
NEUPOGEN contains Filgrastim. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is NEUPOGEN a controlled substance?
NEUPOGEN is not classified as a controlled substance by the DEA.
What is the generic name for NEUPOGEN?
The generic name for NEUPOGEN is Filgrastim. There are 9 other brand versions of Filgrastim.
What is the NDC code for NEUPOGEN 300 ug/mL?
The NDC (National Drug Code) for NEUPOGEN 300 ug/mL is 55513-530, listed by Amgen, Inc.